Method for repurposing ndc codes in a pharmaceutical database for allergens

ABSTRACT

A method for adjudicating reimbursement for allergens includes obtaining National Drug Codes (NDC&#39;s) for a plurality of allergens, storing in a central control database the obtained NDC&#39;s in association with an associated AWP and associated information for the allergen, which associated information includes translation information to allow practitioners to determine from a desired diluted level and number of doses of a desired NDC carrying antigen and a known dilution procedure how to translate back to the amount of base concentration of the NDC carrying antigen used to create the desired diluted level and number of doses, and determining if any of the NDC&#39;s in the central control database are contained within the third-party database and, if not, transferring the associated NDC&#39;s not in the third-party database to the third-party database.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.17/128,301, filed Dec. 21, 2020, entitled METHOD FOR REPURPOSING NDCCODES IN A PHARMACEUTICAL DATABASE FOR ALLERGENS, issued as U.S. Pat.No. 11,755,996 on Sep. 12, 2023 (Atty. Dkt No. RCMD60-35147), which is aContinuation of U.S. patent application Ser. No. 15/235,067, filed Aug.11, 2016, entitled METHOD FOR REPURPOSING NDC CODES IN A PHARMACEUTICALDATABASE FOR VENOM DERIVED ALLERGENS INVOLVED IN VENOM IMMUNOTHERAPY(Atty. Dkt. No. RCMD60-33242), which is a Continuation-in-Partapplication of U.S. patent application Ser. No. 15/171,920, filed Jun.2, 2016, entitled METHOD FOR MANAGING REIMBURSEMENTS FOR PREVIOUSLY NONDATABASE ALLERGENS (Atty. Dkt. No. RCMD-33164), which claims the benefitof U.S. Provisional Application No. 62/169,787, filed on Jun. 2, 2015,entitled METHOD FOR REPURPOSING NDC CODES IN A PHARMACEUTICAL DATABASEFOR ALLERGENS (Atty. Dkt. No. RCMD-32681), and U.S. ProvisionalApplication No. 62/169,785, filed on Jun. 2, 2015, entitled METHOD FORMANAGING REIMBURSEMENTS FOR PREVIOUSLY NON DATABASE ALLERGENS (Atty.Dkt. No. RCMD-32682), the specifications of which are incorporated byreference in their entirety. This application also claims the benefit ofU.S. Provisional Application No. 62/203,819, filed on Aug. 11, 2015, andentitled METHOD FOR REPURPOSING NDC CODES IN A PHARMACEUTICAL DATABASEFOR VENOM DERIVED ALLERGENS INVOLVED IN VENOM IMMUNOTHERAPY, which isherein incorporated by reference in its entirety. This application alsoclaims the benefit of U.S. Provisional Application No. 62/349,626, filedon Jun. 13, 2016, entitled METHOD AND APPARATUS FOR COMPLETINGPRESCRIPTION FOR ALLERGEN COCKTAIL WITH PATCH.

TECHNICAL FIELD

The following disclosure relates to repurposing an existing databaserelated to the pharmaceutical industry and reimbursement for such thingsas allergens involved in venom immunotherapy that are not currentlysupported in the database or only a few of which are supported.

BACKGROUND

Immunotherapy basically involves a series of allergy shots given toreduce one's sensitivity to various allergens that may cause an allergicreaction. This immunotherapy can either be venom based orenvironmentally based. For venom based immunotherapy (VIT), treatmentsare available for allergies to stings such as honeybees, Yellowjackets,Hornets, paper wasps, fire ants and snakebites. For such things asinsect stings, very small amount of the insect venom is injected underthe skin in a dilute saline solution. This type of therapy isrecommended for all patients who have experienced systemic reaction toinsect sting and have specific IgE to venom allergens shown either myskin or blood test. Individuals with a history of a systemic reaction toan insect sting are at an increased risk of subsequent systemic stingreactions. VIT as compared to Environmental Immunotherapy is differentthan pollins and the such that one might be exposed to in theenvironment in that VIT is basically associated with allergens that areflown around inside a special injection device that, when counter, maythreaten the lives of those who are sent to it . . . . Insect venomallergy or snake venom. The primary offenders associated with VIT areprone primarily insects that sting rather than those that might or, asnoted hereinabove, snakes. The insects that sting are typically membersof the order of Hymenoptera of the class insect. This can includemembers of the Vespid family, Yellowjackets, yellow Hornets, white-facedHornets and wasps. There also the class of Apids, including honeybeesand bumblebees. There's also the Formicid family that consists of fireants and Harvester ants.

To desensitize an individual against a particular venom, the process isto immunize the individual with small and graded doses of the venom.This is compared to the use of an anti-venom which is manufactured via apurified process in another animal such as a sheet. For example, theapproved anti-venom for the pit viper (rattlesnake, copperhead and watermoccasin) is based on a purified product made in sheet known as CroFab.These anti-venoms are typically administered through intravenoustechniques. However, there are some antivenoms for such things asstonefish and redback spider that are administered intramuscularly.These antivenoms are injected after a bite, as they are designed to bindto and neutralize the venom, halting further damage, but do not reversedamage already done. This is compared to desensitizing an individual bysmall graded doses.

In general, and antigen is any structural substance that serves as atarget for the receptors of an adaptive immune response or,alternatively, and more simply stated, and antigen is any substance thatcauses an immune system to produce antibodies against it. An allergen isa type of antigen that produces an abnormally vigorous immune responsein which the immune system fights off a perceived threat that wouldotherwise be harmless to the body. These reactions are termed allergies.Thus, by providing small graded doses of venom as the allergen, thiswould produce some type of immune response in the immune system thatwould generate anti-bodies to fight off the perceived threat. For smalldoses, the immune system can initially accommodate this and, as a dosesincrease, the immune system will continue to adapt and build upantibodies to this allergen, i.e., the venom of the particular insect orsnake or other such. These allergens associated with the venomimmunotherapy are specifically associated with allergens that originatefrom the internal organs of animals, insects or reptiles.

Currently, most allergens associated with venom immunotherapy are notreadily reimbursed when received from a pharmacist for the simple reasonthat the NDC code is not included in the database to which thepharmacist has access. Without an NDC code in the database, thepharmacist cannot access that information. By not being able to accessinformation, the pharmacist cannot interface with a benefits providerfor reimbursements nor can they have access to the Average WholesalePrice (AWP), which is the benchmark that has been used for many yearsfor pricing and reimbursement of prescription drugs for both governmentand private payers. Initially, this AWP was intended to represent theaverage price that wholesalers used to sell medications to providers,such as physicians, pharmacies, and other customers. However, the AWP isnot a true representation of actual market prices for either generic orbrand drug products. AWP has often been compared to the “list price” or“sticker price”, meaning it is an elevated drug price that is rarelywhat is actually paid. AWP is not a government-regulated figure, doesnot include buyer volume discounts or rebates often involved inprescription drug sales, and is subject to fraudulent manipulation bymanufacturers or even wholesalers. As such, the AWP, while usedthroughout the industry, is a controversial pricing benchmark.

The AWP may be determined by several different methods. The drugmanufacturer may report the AWP to the individual publisher of drugpricing data, such as Medi-Span. The AWP may also be calculated by thepublisher based upon a mark-up specified by the manufacturer that isapplied to the wholesale acquisition cost (WAC) or direct price (DIRP).The WAC is the manufacturer's list price of the drug when sold to thewholesaler, while the DIRP is the manufacturer's list price when sold tonon-wholesalers. Typically a 20% mark-up is applied to themanufacturer-supplied WAC or DIRP, which results in the AWP figure.

The publishers then in turn sell these published AWPs to government,private insurance, and other buyers of prescription drugs, who use thesedata tables to determine reimbursement and retail prices. Because AWP isa component of the formulas used to determine reimbursement, elevatedAWP numbers can drastically increase the dollar amount that government,private insurance programs, and consumers with coinsurance must pay.

Pharmacies typically buy drugs from a wholesaler and then sell them tothe public. Many patients have coinsurance or copayments, where theyonly pay for a portion of their prescription cost. The insurance companythen pays the rest of the cost (the reimbursement) to the pharmacy.Insurance companies include prescription benefit manager (PBM), healthmaintenance organization (HMO) or government programs, such as Medicaidor Medicare Part B or D. In addition, the pharmacy receives a dispensingfee for filling the prescription. Fees are, for example, set between $3to $5 per prescription, but may vary by state.

Reimbursements are based on AWPs. However, pharmacies purchase drugsbased on the WAC. The difference between the WAC (what the pharmacyactually paid for the drug) and the reimbursement from insurance (basedon AWP) is known as the spread, and equates to the profit that thepharmacy receives.

Market pricing on brand drugs tend to be about 16.6 percent less thanthe AWP. However, the relation of AWP to generic pricing is not clear.Older generics tend to have a large spread between the AWP and WAC,which in turn gives a large spread, and higher profit margins for thepharmacy or other provider of the drug. Many payers, such as PBMS orHMOs, will determine a maximum allowable cost (MAC) pricing on genericsto avoid being overcharged. Newer generic products, compared to oldergenerics, may not have as favorable of a spread, thus the need for MAC.

Collusion between AWP publishers and wholesalers to artificially inflatethe AWP, and in turn increase the spread, has led to court cases in theU.S. In these cases, it was alleged that increasing the spread benefitedthe wholesaler because customers (pharmacies and large institutions)were more likely to buy from them than a competing wholesaler where thespread was not as desirable. The publisher of AWPs profited becausepharmacies were more likely to buy the pricing lists from the publisherthat noted the higher AWPs used in calculating the spread, than to buythem from other publishers with lower AWPs. Due to this pricing fraud,many payers, including government payers, are no longer using AWP forpricing, and are switching to other more transparent pricing benchmarks,such as WAC or AMP (average manufacturers price). However, AWP may stillbe found in use in the U.S. because it has been the standard fordecades.

However, in order for a pharmacist to access the AWP and to be able tointerface with benefits providers, the product associated with an NDCmust be in the database. Currently, nonvenoms are an item that does notexist in the database.

SUMMARY

In one aspect thereof, a method for adjudicating reimbursement for venomderived allergens between a pharmacist and a reimbursing entity isprovided. The method comprises obtaining at a central control centerNational Drug Codes (NDC's) for a plurality of venom derived allergensat a defined concentration level, each NDC uniquely identifying thatparticular allergen as to its manufacture, the particular allergen, thepackaging and the defined concentration level, and further obtaininginformation as to a description of the particular venom derivedallergen, concentration level and manufacturer determining by thecentral control center an Average Wholesale Price (AWP) for each of thevenom derived allergens associated with each of the NDC's, storing in acentral control database the obtained NDC's in association with anassociated AWP and associated information for the venom derivedallergen, which associated information includes translation informationto allow practitioners to determine from a desired diluted level andnumber of doses of a desired NDC carrying venom derived antigen and aknown dilution procedure how to translate back to the amount of baseconcentration of the NDC carrying venom derived antigen used to createthe desired diluted level and number of doses, accessing a third-partydatabase accessible by a pharmacist and determining if any of the NDC'sin the central control database are contained within the third-partydatabase and, if not, transferring the associated NDC's not in thethird-party database and that exist in the central control database foreach of the venom derived allergens to the third-party database inassociation with the AWP and associated information for each of thevenom derived allergens for each of the NDC's, and uniquely associatingeach of the NDC's in the third-party database to the central controlcenter for adjudication information, and creating an adjudicatingdatabase at the central control center having defined benefitsassociated with reimbursable entities for each of the NDC's stored inthe third-party database and in the central control database inassociation with the translation information for each of theNDC-carrying venom derived antigens, wherein a pharmacist can accessthis information by accessing a particular NDC in the third-partydatabase to obtain information regarding reimbursable benefits from thecentral control center and enter the diluted level and number of dosesand a claim with the central control center for adjudication of theamount of base concentrate venom derived antigen used and wherein thecentral control center is able to process any claim made by thepharmacist and reimburse the pharmacist accordingly for the baseconcentrate venom derived antigen used to provide the desired dilutedlevel and number of doses of the desired NDC carrying venom derivedantigen.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding, reference is now made to thefollowing description taken in conjunction with the accompanyingDrawings in which:

FIG. 1 illustrates a general diagrammatic view of the overall interfaceof basic databases;

FIG. 1A illustrates an NDA code;

FIG. 2 illustrates a diagrammatic view of a database that is populatedby a central control system;

FIG. 3 illustrates a flow chart for the operation at the central controlsystem for receiving NDCs from the manufacturer;

FIG. 4 illustrates a flow chart for the operation of populatingthird-party database by the central control system;

FIG. 5 illustrates a flow chart for the operation at the pharmaceuticallocation;

FIG. 6 illustrates a flow chart for the overall generation of the AWPand the interface with the benefit providers;

FIG. 7 illustrates a diagrammatic view of flow beginning at the pricktest and following through to filling the prescription at the pharmacistlocation;

FIG. 8 illustrates a flowchart for interfacing with database foraccessing benefits by the pharmacist;

FIG. 9 illustrates a flowchart for the parsing operation at the databasefor parsing non-NDC allergens to an NDC-bearing base concentratedallergen;

FIG. 10 illustrates a diagrammatic view of a dilution sequence ofdiluting a concentrated antigen extract;

FIG. 11 illustrates a process flow for diluting an antigen extract;

FIG. 12 illustrates a process flow for the overall distribution chain;

FIG. 13 illustrates a process flow for multiple extracts;

FIG. 14 illustrates an alternate embodiment of FIG. 13 ;

FIG. 15 illustrates a flowchart for one example of processing aphysician script;

FIG. 16 illustrates a diagrammatic view of a table in a relationaldatabase relating distributed doses back to NDC-bearing dose;

FIG. 16A illustrates a diagrammatic view of a table showing the dilutionprocedure;

FIG. 17 illustrates a second example of that illustrated in FIG. 15 ;

FIG. 18 illustrates a diagrammatic view of processing of a scriptreceived from a physician at a pharmacist to compound a patient-specificdosage;

FIG. 19 illustrates an alternate embodiment of that illustrated in FIG.18 ;

FIG. 20A illustrates a diagrammatic view of a process of filling ascript received from a position and FIG. 20B illustrates a tableassociated with such process;

FIG. 21 illustrates an overall process flow illustrating the prick test,the script flowing through to the final patient does; and

FIG. 22A illustrates a flowchart for parsing an antigen having a basedose with more than the prescribed antigens and FIG. 22B illustrates atable associated with the parsing operation.

DETAILED DESCRIPTION

Referring now to FIG. 1 , there is illustrated a diagrammatic view ofthe overall system for transferring NDC's between systems. The NDC, orNational Drug Code, is a unique 10-digit, 3-segment number. It is auniversal product identifier for human drugs in the United States. Thecode is present on all nonprescription (OTC) and prescription medicationpackages and inserts in the U.S. The 3 segments of the NDC identify thelabeler, the product, and the commercial package size. The first set ofnumbers in the NDC identifies the labeler (manufacturer, repackager, ordistributer). The second set of numbers is the product code, whichidentifies the specific strength, dosage form (i.e, capsule, tablet,liquid) and formulation of a drug for a specific manufacturer. Finally,the third set is the package code, which identifies package sizes andtypes. The labeler code is assigned by the FDA, while the product andpackage code are assigned by the labeler.

For example, the NDC for a 100-count bottle of Prozac 20 mg is0777-3105-02. The first segment of numbers identifies the labeler. Inthis case, the labeler code “0777” is for Dista Products Company, thelabeler of Prozac. The second segment, the product code, identifies thespecific strength, dosage form (i.e, capsule, tablet, liquid) andformulation of a drug for a specific manufacturer. In our case, “3105”identifies that this dosage form is a capsule. The third segment is thepackage code, and it identifies package sizes and types. Our exampleshows that the package code “02” for this bottle of Prozac identifiesthat 100 capsules are in the bottle. The FDA maintains a searchabledatabase of all NDC codes on their website. This is illustrated in FIG.1A.

The NDC codes are unique codes that are applied for and assigned tospecific individuals to be associated with specific products. Eachmanufacturer of allergens, for example, has a unique NDC associated withthe product that they provide, which is assigned to that manufacture forthat product based upon their applying for such. The manufacturer,therefore, has full ownership of that NDC. In order for that NDC toappear in a database with the associated information the approval ofthat manufacture is required. For example, a manufacturer of awell-known drug will provide information to the database and populatethat database and the record associated with that NDC with theinformation regarding that product associated with that NDC but theywill also define what the AWP is for that product. It is themanufacturer, not the person that controls the NDC of the manufacturer,that controls what is in database, including the AWP. Additionally, itshould be noted that a distributor could actually apply for an NDC andcould populate or associate with that NDC information regarding aparticular product. They could actually place this NDC that they own,this being a unique NDC, in a database with another NDC, a different andunique NDC, that will be associated with basically the same product.This, of course, would provide some NDC contention within the databasewhich is to be avoided if possible.

Thus, a manufacturer 102 has associated there with its own proprietarydatabase 1044 to store their NDCs. This can be provided to a centralcontrol center 106. The central control center 106 desires to haveaccess to these NDCs of the manufacturer 102. This is the primary reasonthat these NDC's do not exist in any other database. Typically, thecentral control center 106 would have some type of contractualrelationship with the manufacturer 102 for the purpose of maintainingsome type of exclusivity with respect to the manufacturer's NDC.Thereafter, these NDC's are stored in a central control database 108. Inthis database 108, the central control 106 can modify the information.Primarily, the main aspect that they had is the AWP. This allows thecentral control 102 to control this AWP. There is, of course, thewholesale cost exactly charged for the product to an end user such as apharmacist, but the AWP is the benchmark price. This is not necessarilythe price that the pharmacist, for example, will charge to the customerbut, rather, it is the benchmark price. Further, this is not even theprice that will be reimbursed to the pharmacist even if the pharmacistbilled the customer for such. Thus, of course, this would not result inany type of price-fixing; rather, all that is controlled by the centralcontrol 106 is the inclusion of AWP within the database. This AWP can beutilized by the reimbursing entities and the such for centering on afinal reimbursement price.

In this disclosed embodiment, the data associated in with these venomderived allergens is then downloaded into a third party database 110associated with a third-party information provider. This informationprovider is one of many information providers that provide accessthrough a network 112 to a pharmacy 114. It is noted, however, that thecentral control 106 first confirms that none of the NDC's associatedwith any of the venom derived allergens is actually currently in thethird party database 110. Once these NDC's and their associatedinformation and associated AWP's are stored in the third party database110, the central database 108 has some control over both the informationand the AWP associated with each of the NDCs. Thus, when a pharmacistreceives a request from a physician to fill a prescription for a venomderived allergen for delivery to the physician, the pharmacist canaccess the third party database 110 and determine that this is, in fact,in the database and is a reimbursable prescription.

Referring now to FIG. 2 , there is illustrated a diagrammatic view ofthe third party database. This includes, in one column, NDC's, and asecond column AWP's and in a third column information regarding theproduct associated with the NDC.

Referring now to FIG. 3 , there is illustrated a flowchart depicting theinitial operation of populating the database 108. The central control106 initiates the process at a block 202 and proceeds to block 304 inorder to receive the NDC from the manufacturer with the associatedinformation regarding the associated product. This is one associatedwith product in the database of the control center 106 and also withproducts controlled by the control center 106. The control center 106 istypically associated with some type of distribution center such that, inthe information that they associate with the NDC in the database 108,the control center 106 and the entity associated therewith are thedistribution arm for that product, i.e., this is where the product isordered from by the pharmacist. The program then proceeds to a block 308wherein the AWP for that particular product and associated with that NDCis defined. This is a number that is set at whatever level is determinedto be correct and appropriate by the control center 106. There are anumber of reasons for the price being set at any level. There is, ofcourse, some cost of buying a product from the manufacturer 102, themarkup and expenses associated with the operation of the control center106, resulting in a wholesale price to the pharmacist. This wholesaleprice is not necessarily associated with the record that is stored inthe database 110. However, it is this information that is utilized indetermining what the AWP will be for that NDC and associated product. Anumber of factors, of course, enter into that calculation, includingpractical knowledge of how the insurance industry reimburses for venombased allergens. After processing, the information is stored in thecentral control database 108.

Referring now to FIG. 4 , there is illustrated a flowchart depicting thetransfer of data, which is initiated at a block 404 and then proceeds toa block 406 to access the third-party database through the network 112.The program then flows to a function block 410 to confirm that no NDCsin the control database 108 exists within that third-party database 110.The program then flows to a function block 412 to populate thethird-party database 110 with information from the control database 108,which, as described above, includes the information from themanufacture, information regarding the central control center 106 asbeing a source of the product and the AWP for that product, allassociated with the NDC for that product. The program that flows to aterminate block 414.

Referring now to FIG. 5 , there is illustrated a flowchart for theoperation at the pharmacy. This is initiated at a block 502 and thenproceeds to a block 504 wherein the pharmacist receives a request from aphysician for a venom derived allergen. This might actually be presentedto the pharmacist by a patient which desires to receive the venomderived allergen for dilution and processing by the pharmacist or it mayin fact be an already diluted venom derived allergen that could beactually self-administered by the patient. The program then flows to adecision block 506 to determine if the product is in stock. If theproduct is in stock, the program flows to a function block 512 to checkthe database for reimbursement and, if not, the program flows to a block510 to process a stock item by whatever procedure the pharmacistutilizes. When checking the database, the pharmacist enters the NDC ofthe product, as indicated in a block 514. The program then flows to adecision block to determine if the NDC is found, this being block 516.If not found, the program exits and, if found, the program flows thefunction block 518 wherein the pharmacist can view the AWP for thatproduct. This gives the pharmacist some idea as to what might bereimbursable, but also, the insurer itself will illustrate some type ofpotential co-pay. This just indicates the amount that the patient willpay at the counter. The pharmacist then can enter an amount that thepharmacist will claim that they want to be paid for this particularproduct. It may be less than the AWP but not more than AWP. This, ofcourse, is a function of what the pharmacist desires. This is indicatedby block 520. Thus, there is provided a third-party database 110 havinginformation contained therein, which is controlled by the centralcontrol center 106 with respect to the venom derived allergens. Part ofthis is the AWP and part of it is the source for that venom derivedallergen. The insurer has access to this information and can utilize itto adjudicate a claim. Information from the insurer can be linked tothis database indicating a co-pay, for example. With respect to this,and insurer can indicate that it will pay the entire cost of theparticular venom derived allergen or indicate what percentage of thevenom derived allergen that it will pay for. Sometimes, it is just aco-pay. However, for some very expensive venom derived allergens, theinsurer may over time decide that it only pays a small percentage of thevenom derived allergen. This will be on an allergen-by-allergen basis.By allowing this third-party database 110 to be controlled by thecentral control center 106 with respect to the cost for the particularvenom derived allergen, this allows central control center 106 tocontrol the adjudication of the particular venom derived allergen. TheProgram then flows to a function block to send a request to thethird-party payee for reimbursement, as indicated by block 522.

The process for adjudicating any claim requires that some entity orparty has worked with the insurance company or the reimbursing entity tonegotiate the particular reimbursement or any benefits that areprovided. If the pharmacist is apprised of an AWP in the database for aparticular venom derived allergen, they at least have a price that theycan charge for the product. For example, if the pharmacist has a producton the shelf with an NDC any position writes a prescription for thatvenom derived allergen, the pharmacist just needs to know how much tocharge the patient. By accessing the third-party database 110, the AWPcan be determined. However, that alone doesn't allow the pharmacist todetermine whether benefits are associated with that particular venomderived allergen. In order to do that, there has to be some link betweenan adjudicating party or entity. The pharmacist can select the NDC and afield (not shown) that directs the pharmacist to an adjudicating partyor entity to provide information as to benefits that are available. Ifsuch indicates that benefits are available, then the pharmacist knowsthat they can make a claim to this adjudicating party.

In the current disclosed embodiment, the central control center 106maintains the adjudicating database. The central control center 106 isresponsible for interfacing with insurers and the such to provide thesebenefits. For example, if there are five major insurance companies thatreimburse the pharmacist or even Medicare, the central control center106 will make the arrangements for reimbursement and allow thepharmacist to determine whether the patient, who may be associated withany of these reimbursement entities, can receive benefits. If, forexample, the patient had insurance with Insurer A, and central controlcenter 106 had negotiated with Insurer A for certain benefits, thiswould be made available to the pharmacist. The benefits might providefor some type of co-pay which the pharmacist could charge to the patientand then the pharmacist could make a claim for the remaining value ofthe venom derived allergen to the adjudicating party, i.e., in this casethe central control center 106. The central control center 106 wouldthen process the claim and forward a check to the pharmacist. Since thecentral control center 106 populated the third-party database 110 withall of the NDCs, the central control center 106 has exclusive rights toadjudicate these NDCs and the associated venom derived allergens. Thus,this unique link from the third-party database 110 to the centralcontrol center 106 allows all claims to be adjudicated therethroughbecause the central control center 106 has exclusive control over theseNDC for these venom derived allergens.

All of the NDCs, as noted hereinabove, or for venom derived andallergens that are to be dispensed to a patient are a single dose venomderived allergen. Thus, each of the NDCs that would be obtained by themanufacturer would be for single dose venom derived allergens ratherthan bulk venom derived allergens that are currently provided.

FIG. 6 illustrates a flow chart depicting the operation wherein thecontrol center is able to determine the AWP by interfacing with thebenefit providers. This is initiated at a block 602 and then proceeds toblock 604 wherein the control center assembles the various costinformation regarding the manufacturers cost to the control center, theexpenses of storing the venom derived allergen at the control center,i.e., where the control center is the distributor and provider of thevenom derived allergen, and what kind of markup or profit margin thecontrol center expects to receive on a venom derived allergen. Theprogram then flows a function block 606 to determine the AWP. This AWPis based on the information retrieved in block 604 and then a ceilingfor the AWP is determined. This ceiling is a number that is arrived atby the control center based upon their knowledge of how the benefitproviders reimburse pharmacists and the such. Since the AWP is a ceilingand the pharmacist cannot charge more than that, they provide a numberthat is a benchmark for the industry. By determining this benchmark, theinsurance industry will typically center in on a lower reimbursableprice, depending upon how valuable they think a particular venom derivedallergen or the such is to the industry. For example, if they sold theproduct for $350 to the pharmacist, this being the wholesale price, theymight set the AWP at $500. Over time, pharmacist may actually make aclaim for only $450 which, at first, the insurance copies may reimburse.After a time, the insurance industry may come to the conclusion thatthis venom derived allergen is only reimbursable at a rate of $400.

The program then flows to a function block 612 wherein a control centercan interface with benefit providers to determine what the reimbursementlevels are and, if necessary, adjust the AWP. However, they can alsodetermine such things as rebate programs and incentives and the suchthat they can provide to the pharmacist, as indicated by a functionblock 614. Since they control the database, they can also writeinformation from the interface with that particular part of thedatabase. The program then flows to a function block 616 to adjust theAWP if necessary and then into a function block 618 to adjust theinformation in the database if necessary.

The overall operation of initially testing patient at the physician'soffice, writing a script for the patient and completing the prescriptionby processing that script at a pharmacist location or some type ofcompounding pharmacy operation. In general, it must be noted that eachscript is very patient-specific; that is, in a system that is unique totesting for venom derived allergens, it is necessary to determine whichof multiple antigens must be combined in a desensitization program. Itmay be that, for example, a prick test initially indicates that thepatient is highly allergic to cat fur, dog care, various types ofpollen, certain venoms, and the such. With a positive indication forthese particular venom derived allergens, the physician can thendetermine which antigens need to be combined in some type of prescribeddosage regimen. Since there are so many venom derived allergens that canexist and since each patient is an individual, this combination can besomewhat daunting if the desire of the industry were to provide onlythat particular combination as a “drug” that has an NDC associated therewith. This is practically impossible, of course.

Referring now to FIG. 7 , there is illustrated a flow diagram of theoverall process of determining a particular combination of antigens todesensitize an individual and the regimen therefore. This is initiatedat a block 702 wherein the physician subjects the patient to what isknown as a “prick” test. This prick test is a test whereby the physicianintroduces a small amount of venom derived allergens into a small areaon the skin of an individual. There can be multiple spots that arearranged in a grid on, for example, a portion of the back of thepatient. These allergen locations are recorded and then they areobserved over a certain period of time. There is also typically sometype of base allergen that is provided such as a hypoallergenic antigenand a hyper allergenic antigen such that there is an area that willresult in no response and as an area that will result in a guaranteedresponse. Upon observation, areas that elicit a positive responseindicate that the patient is sensitive to that particular allergen. Itmay be that the patient is very sensitive to certain of the allergensand just mildly sensitive to others. The physician then determines whichof the allergens need to be included in a desensitization program. Forexample, if an individual in Texas showed a positive response to someallergen that rarely occurred in Texas, the physician might not includethat in a desensitization regimen.

Once the regimen is set upon for a particular patient, a script is thenwritten by the physician, as indicated by block 704. This can be ascript for a single venom derived antigen if that was all that wasrequired for a desensitization program or it could be for a cocktail ofmultiple venom derived antigens. The physician will define the venomderived antigen or antigens that are to be included in the regimen, thedosage level and the carrier. For example, for the first desensitizationlevel, the most diluted level of antigen will be utilized. Typically,the physician will require that the single venom derived antigen orcocktail of antigens be provided in a carrier such as saline or glycerolin a vial that will allow for a certain number of injections. It may bethat the physician wants to prescribe for this first desensitizationlevel a dosage that will allow for three injections per week for threeweeks.

This script is then written and provided to the patient or it can bedirectly delivered to the pharmacist, as indicated by a path 706 to ablock 708 indicating the pharmacist. The pharmacist then creates apatient-specific venom derived antigen cocktail, as indicated by block710. The pharmacist then lists the antigens that are contained withinthe cocktail, noting that there could be a single antigen. This isindicated at a block 712 and then the pharmacist accesses the databasefor price and benefits. This is basically the Pharmacy Benefits Manager(PBM) database, which contains all of the drugs, etc., that areavailable for reimbursement. If the pharmacist, for example, looks up aparticular antigen that was prescribed in the script and does not findit, this indicates that it is not something that can be reimbursed. If,however, this antigen exist within the database, it indicates both theAWP for that antigen and benefits associated there with. All of this ispre-populated within the database. However, with respect specifically toany antigen, the NDC for that antigen will only be associated with thebase concentrate level. The script, however, is for a particular diluteddosage of that particular antigen and even a combination of multipleantigens at that particular dosage. This database is accessed at a block714 and then, after access is complete, as indicated by a decision block716, the prescription is filled at a block 718. The operation ofdetermining the particular AWP and benefits associated with any scriptfor antigens at any dosage level, wherein the particular combination ofantigens does not have particular NDC associated therewith nor does anyantigen by itself have a particular NDC associated therewith, it isnecessary to cross correlate this with an NDC that has an AWP associatedtherewith. Further, with respect to antigens specifically, the currentNDC for any antigen is associated with the base concentrated materialand this base concentrated material is too toxic to utilize at thatconcentration level. Thus, anything that is distributed to the patientwill always be diluted from this base concentrated material. As will bedescribed hereinbelow, it is always necessary to cross correlate anydosage level back to the NDC for the base concentrated material in orderto determine benefits. Further, each of the scripts set forth by thephysician will always have a list of each of the one or more allergensto which the patient exhibited a level of sensitivity thereto and theantigens associated there with. Further, the physician will determinethe dosage level also. This is indicated by block 720.

Referring now to FIG. 8 , there is illustrated a flowchart depicting theoperation of accessing the database, which is initiated at a block 802and then proceeds to a decision block 804. The decision block 804determines whether a request for access has been received and, if so,the flowchart proceeds to a block 806 to determine if the particularrequest of the PBM database is associated with that for an antigen. Ifnot, the program will follow the “N” path to a block 802 to proceedalong the normal benefit determining process. This is not describedherein. If, however, the request is for an antigen, this is a specificoperation, since the only NDC that exists is for a base concentratedantigen that is too toxic to be directly distributed to a patient or foranother dosage level that is to be diluted. Once an antigen NDC asindicated, the program flows to a block 810 in order to receive the NDCfor the base antigen or antigens and then to a block 812 to receive thedose level for all of the antigens, as well as the carrier and thedilution procedure that is utilized. The program will then flow to ablock 814 in order to cross reference the particular dose level that wasactually distributed to the patient to the dose of the highestconcentrated level of the base concentrate material. This will be on aparsed operational level. This parsed operational level means that, forexample, if 10 antigens were distributed in a cocktail, it would benecessary to cross reference the distribution of this particular dosagelevel to the actual material utilized from the NDC-carrying baseconcentrated level. If, for example, for a single base concentratedmaterial that yielded an antigen in the cocktail mixed, required 1 mLout of a 50 mL bottle, the benefits for that one milliliter could bedetermined, as this is a “dosage” of the base concentrated level that isassociated with an NDC. As indicated by a block 816, the benefits can bedetermined for “each” allergen at a base or lowest concentrated levelthat is associated with an NDC. It is noted that an NDC might beprovided for an already diluted level of a particular antigen. However,it is always necessary to determine what portion of the NDC-carryingmaterial is utilized down to the final diluted level and then crosscorrelate this back to the NDC-carrying material at its particulardilutant level, this requiring some information as to the procedure fordilution, the carrier, etc. in order to adequately determine exactly howmuch of the NDC-carrying material was utilized. The program thenproceeds to a block 818 to then access the benefits and then to a block822 to end program.

Referring now to FIG. 9 , there is illustrated a flowchart for theparsing operation, which is initiated at a block 902. The program thenproceeds to a block 904 in order to receive the prescribed scriptlevels. The program then proceeds to a block 906 in order to parseantigens in the cocktail to individual antigens (noting that a singleantigen could be provided for). The program then flows to a block 908 inorder to cross correlate each of the parsed antigens and the script doselevel back to the base concentrated amount, noting that this requiresthe carrier to be known, the procedure to be known for dilution. Sincethe script merely states that the most diluted level must be providedfor, the pharmacist then to provide that particular antigen. Theparticular base concentrated antigen could be at different concentratedlevels which would require a pharmacist to utilize one of multipledilution procedures to obtain the final diluted level desensitizationregimen. However, as will be described hereinbelow, it could be thatphysician prescribes a particular antigen in the cocktail that can befound in an antigen at a base concentrated level that contains multipleantigens. This is very common in the industry. For example, somecompanies deliver already mixed cocktails for various types of pollen.If the physician only prescribed one out of these types of pollen, thenthis procedure must be noted so that particular amount of baseconcentrated material, that can be reimbursed based upon its NDC, couldbe allocated. For example, if it were determined that 1.0 mL of the baseconcentrate pollen cocktail were required in order to get the prescribedamount of the one type of pollen, and this was from a mL bottle, thiswould indicate a 1 mL dosage of the base concentrate level, but thiswould be divided by the number of particular antigens that are in thebase concentrate material. If there were, for example, ten antigenscontained in the cocktail, then this would be divided such that only1/10^(th) of the dosage would be applied to benefits. That is, a 50 mLbottle would be considered as containing, assuming that the startingdosage is always 1 mL or any deleting process, as having 500 dosages ofindividual antigens. This, of course, requires knowledge of the dilutionprocedure, as indicated by a block 910. Once the crosscorrelation iscomplete, the program proceeds to a return block 914.

Referring now to FIG. 10 , there is illustrated a depiction of atechnique for diluting immunomodulators such as antigens, as oneexample. Preparation of a diluted antigen is performed first byreceiving a bottle of extract concentrates at a base concentrate levelfrom an approved vendor. These are formulated in a given weight/volume(w/v) format with a given antigen associated therewith. For typicalantigens such as those associated with the cat antigen, these arerelatively well controlled. Typically, a vendor will provide an extractfor a single antigen or allergen. Allergens such as pollen and the suchare not as well controlled due to the technique for collecting such. Inany event, there are typically very few approved vendors for theseextracts and an allergist typically receives these vendor providedconcentrates in a sufficient quantity to make the necessary dilutedsolution.

Allergen extract is typically comprised of a non-allergenic material, anon-allergenic protein and an allergenic protein. The extractionsolutions can be aqueous containing saline and phenol work could be aglycerinated solution. The allergen is added, the units of measure aresometimes referred to as “AU” for “allergy units,” typically used formites. These are referred to as “AU/mL.” For such things as grass andcat, the term “BAU” is used for “bioequivalent units.” For otherallergens, the terminology is, for example, 1:20 w/v, which stands for 1g source material per 20 mL of fluid. The relationship between BAU and1:20 w/v depends upon the extract. In any event, there is a definedamount of extract contained within the concentrate.

When concentrated extracts are formulated by an authorized vendor, theyare typically provided in standardized versions and non-standardizedversions. In standardized versions, they typically are provided in a 50%glycerin dilutant. They can either be a single allergen extract or theycan be a mix. For example, one can obtain a “9 Southern Grass Mix(concentrate)” which contains equal parts of: 2 Bermuda at 10,000BAU/mL, P27 7 Grass at 100,000 BAU/mL, 15 Johnson at 1:20 w/v. Fornon-standardized extracts, these are typically provided in either aglycerin dilutant or an aqueous dilutant such as saline. They can be asingle extract or a mix. Thus, whenever a concentrated extract isreferred to hereinbelow, this refers to a formulation that is providedby an authorized vendor that can be diluted in accordance with theprocesses described hereinbelow. These are typically provided in the 50mL bottles with a needle compatible.

Referring back to FIG. 10 , the extract concentrate is disposed in abottle 1002. This is a sterile concentrate that has an injectionstoppered top 1004. There are provided a plurality of five 5 mL sterileinjection stoppered bottles 1006, 1008, 1010, 1012 and 1014, althoughthere could be more and the bottles or containers could be larger than 5mL. Each of these bottles has disposed therein a defined amount ofdilutant, depending upon what the final required to be. Typically, theamount of dilutant is 4.5 mL. The procedure is to, first, extract adefined amount of the concentrated extract from the bottle 102 anddispose it in the bottle 1006. This is facilitated by the sterilehypodermic that is inserted through the stopper at the top of the bottle1002 to extract concentrate and then the hypodermic is inserted to thestopper in the bottle 1006 to inject extract from bottle 1002 intobottle 1006. Typically, the concentration in the concentrated extractbottle 1002 is 1:20 w/v. This will result in a dilution of 1:10 inbottle 1006. If the amount injected is mL. Then, 0.45 mL of the dilutedsolution from bottle 106 is then extracted and inserted into bottle1008, resulting in a 1:100 dilution of the original concentrate inbottle 1008. The process is repeated up to the bottle 1014 to provide asolution that is at a dilution of 1:100,000 of the original concentrate.This is a conventional way to provide a selected dilution of theoriginal antigen. However, it should be understood that anyconcentration level can be provided from one bottle to the next. Thepurpose of using the sequential bottles is to allow an achievableportion of one bottle to be distributed to the next bottle, rather thantrying to extract a very small amount of the initial concentratedextract. Typically, an allergist will then extract from the desireddilution an amount of the diluted antigen for injection percutaneously.Typically, desensitization is achieved by using the most diluted antigenlevel initially and sequentially moving up to a higher concentrationlevel over time 1.

Illustrated in FIG. 10 are three hypodermic needles, one selecting a“dose” from bottle 1014, and labeled hypodermic 1016, a secondhypodermic needle 1018 for retrieving a dose from bottle 1012, a thirdhypodermic needle 1020 for extracting a dose from bottle 1010. Each ofthe hypodermic needles 1016, 1018 and 1020 will contain a differentdiluted dose. These would typically be separate needles in the eventthat the allergist or medical professional is injecting a patient. Forother purposes, they could be the same needle, depending upon the doseor concentration required. A “dose” is defined as the amount of all thediluted product that would be required for the desired immunotherapy.This is defined by the medical professional. If, for example, bottle1012 were utilized, it may be that 1 mL of diluted solution constituteda “dose.” It could be that less than 1 mL constituted a “dose.”

This entire procedure is provided as a “data” procedure which can bedesigned for particular carriers and the such. Additionally, the carriercould be a transdermal cream which could be mixed by the pharmacist. Anycarrier that is able to contain one or more diluted antigens at anyprescribed dilution level can be utilized.

Referring now to FIG. 11 , there is illustrated a process flow for theembodiment of FIG. 10 . This is initiated at a process block 1102 andthen proceeds to block 1104 wherein a certain amount of concentratedextract is received from a vendor, this being a qualified or authorizedvendor for the extract. This is typically at a predetermined concentratelevel of, for example, 1:20 m/v. The process then flows to a block 1108wherein a defined quantity of, for example, 0.45 mL is transferred to a5 mL bottle which already has a quantity of 4.5 mL buffered salinesolution disposed therein. The process then flows to a block 1110 todetermine if this was the last dilution step needed, as describedhereinabove, depending upon what level of dilution is necessary. If, forexample, by steps of dilution are required for a particular patient, andall five steps would be processed. However, it is not necessary to doall five steps if an intermediate dilution is required. This essentiallycustomizes the overall operation for a particular patient. Further, theindustry is so regulated such that only 5 mL bottles can be utilized forthis dilution process. Thus, it will only be a maximum of 5 mL ofdiluted material available at any step prior to proceeding to the nextstep. Thus, if all 5 mL are required, then the next step is not desiredor useful. If it is not the last dilution step, the process flows to ablock 1112 to extract 0.45 mL of diluted antigen from the current 5 mLbottle and then flows back to the input of the process block 1108 afterincrementing the bottle count at a block 1114. This continues until thelast dilution, at which time the process flows from the block 1110 to aterminate block 1116. Again, any type of carrier could be utilized andbottles larger than 5 mL could in fact be utilized. This all dependsupon the number of “doses” at a particular diluted level that arerequired by the physician right the initial script or prescription.

Referring now to FIG. 12 , there is illustrated in overall flow of theoperation of moving concentrated antigen from a vendor to an end uservia a pharmacist. As noted hereinabove, the liquid antigen in aconcentrated extract at the base concentrate level that has associatedthere with an NDC was first received from a vendor that assigned thatNDC, which is basically a combination of a single antigen or antigenssuspended in a sterile agent. This is indicated by a block 1202. Theantigen is then diluted by the pharmacist from this extract to a desireddiluted level, as indicated by a process block 1204. This is combined ina block 1206 with a sterile carrier and containment material, i.e.,sterile saline solution or, even a transdermal cream, for distributionto a patient. This, as described hereinabove, will typically be adefined number of doses of a single diluted antigen or multiple dilutedantigens, wherein a dose is again defined as being a typical dose that amedical professional would administer to a patient in an office visitnecessary to achieve a therapeutic result for which a patient couldadminister to themselves. This is either transferred as a combinedantigen (diluted)/encapsulation product for storage on a shelf, asindicated by a block 1212, or it would be transferred to a medicalprofessional for a patient for management and disposition.

Referring now to FIG. 13 , there is illustrated a diagrammatic view ofthree different extracts of antigens/allergens 1302, 1304 and 1306. Eachof these is for a particular antigen or allergen. The first two are forantigens respectively associated with a cat and a dog. The third is foran allergen associated with pollen. They are each diluted in accordancewith the process described hereinabove with respect to FIG. 10 . Asillustrated, the antigen extract in bottle 1302 is transferred as adiluted level to either an encapsulation material in a container 1310 or1312, each at a different diluted level. This is similarly the case withrespect to the antigen in bottle 1304 and the allergen in 1306 whereinthe diluted level of the antigen in the bottle 1304 is disposed incontainers 1314 and 1316 and the diluted level of the allergen in bottle1306 is disposed in containers 1318 and 1320. Typically, any extractwill be 100% pure with respect to the particular extract. Theseconcentrated extracts are not typically mixed, which is typically afunction that the medical professional or compounding pharmacist willperform. This, of course, is a customized mixture for a particularpatient, i.e., this is a patient-specific combination as defined by themedical professional in the script provided to the pharmacist. Forstorage on the shelf, the operation of FIG. 13 will be facilitated inorder to ensure that the containers 1310-1320 contained only a singleantigen. Thus, when transferring the container to a store, for example,this would be stored on the shelf as a single allergen combination ofthe base concentrate level.

Referring now to FIG. 14 , there is illustrated an alternate disclosureto that of the embodiment of FIG. 13 . In this embodiment, each of theimmunomodulators or antigens at the concentrated levels in the bottles1302-1306 are diluted in accordance with the process noted hereinabovewherein they are sequentially diluted in the associated 5 mL bottles.However, note that only a maximum of 5 mL can be extracted from a givenbottle at the last dilution level. If, in this example, it is desired todistribute a predefined number of doses to a final carrie having a fixedamount of carrier such as saline disposed therein and each dose added tothat material will provide the final overall dosage or, alternatively, aviscous transdermal cream can be utilized that is initiated at anoriginal fixed value in grants such that each dose will be associatedwith a single gram of that transdermal cream material, and then theamount of diluted antigen must be adjusted such that single dose iscontained within 0.3 mL of the material. Thereafter, if 3 mL of antigenis extracted from a given bottle, this constitutes 10 doses such that asingle dose will be associated with a single dose of the finalencapsulation material. In this example, from each of the last dilutionbottles for each of the concentrate bottles 1302-1304, 3 mL is extractedand inserted within the container 1402 containing prescribed level ofcarrier material, be that saline solution or a transdermal cream. Thus,for each milliliter of saline solution, for example, or each gram oftransdermal cream material, there will be a single dose of theparticular antigen associated there with. Thus, the carrier material inthe container 1402 now acts as a consolidator of all of the antigens fora cocktail.

Referring now to FIG. 15 , there is illustrated a flowchart depictingone example of the generation of a script for a single antigen andfilling of that fiction based on that script and getting reimbursedtherefor. This is initiated at a block 1502 and then proceeds to a block1504 in order to prepare the physician script for a single antigen. Theprogram then flows to a block 1506 in order to define the requirementsof the maximum dilution for the initial desensitization. The physiciandefined at which level the script is written for. For example, thephysician sets forth a regimen. This regimen defines six levels ofdilution of a defined NDC base concentrate antigen, each level ofdilution are required for a predetermined amount of time. For example,the most diluted level might be required to be administered in threedoses per week for three weeks for total of nine doses. The first scriptwould require the pharmacist to deliver to the patient a vial containingnine doses at that diluted level of the at least a single antigen. Thephysician could then require the second higher level to be provided overthe course of one week at three doses per week. This might require asecond script to be filled by the pharmacist or, alternatively, thepharmacist could fill that script that same time and maintained thatparticular vial on the shelf for distribution to the patient at a latertime, all of this depending upon the script provided by the physician.Of course, the physician could require the patient to come into theoffice for observation and then write another script. This would be aseparate and distinct operation and prescription which would beindependently associated with a different set of benefits possibly.

After the dilution level is determined for the initial desensitizationor at any level in the desensitization regimen, the program flows to afunction block 1508 wherein the pharmacist selects concentrate antigenand then goes to the dilution process required in order to achieve thedesired diluted level. The program then proceeds to a function block1510 wherein the pharmacist enters the NDC code for the base concentratelevel and the script level. Basically, what the pharmacist does is enterthe antigen name and the dosage level provided by script. The programthen proceeds to a function block 1512 in order to perform a lookup inthe PBM database for the particular antigen that is associated with thescript. This lookup does a correlation, as will be describedhereinbelow, to the lowest concentrate level having an NDC for thatparticular antigen. Knowing the dilution level and the procedure, it ispossible to determine what amount of the NDC-carrying concentrate levelfor that particular antigen was utilized and then a reimbursementobtained therefor. This is indicated by the function block 1514 and1516. The program then flows to an initial End block 1518.

Referring now to FIG. 16 , there is illustrated a table for a singleantigen and the overall crosscorrelation information. This is arelational database. In this table can be seen that there is provided acolumn for the NDC code which is populated for a particular antigen.This indicates the name of the antigen and also information associatedthere with. There is also a dilution procedure for multiple proceduresthat can be associated with administering this particular antigen. Sincethe NDC code is not associated only with the type of antigen but alsothe concentration levels, this will be associated with the dilutionlevel to determine what the various dilutant levels are in the overallstandard process. As noted, the base level is indicated by a dilutantlevel D1 or a base concentrate level there than provide five additionaldilutant levels D2 through D6. Each one of these dilutant level columnshas associated there with a particular range of dilutant levels. Asindicated by example, there are levels 1 through 3 for each of dilutedlevels, with more possible. Therefore, if the most diluted level, D6were selected and that the procedure required that the dilutant level Z6for the dilutant level column D6 were selected as the end dilutant levelthat was required by the physician in the script provided to thepharmacist, this would be what was put into the PBM system. However,there is no NDC associated with this particular antigen at thisparticular dilutant level. Therefore there must be some crosscorrelationback to column D1 for the base concentrate level, which column has anNDC associated there with. If the final dilutant level was Z6, thiscould be cross correlated back within the same row to the dilutant levelZ1 of the base concentrate. However, although not shown, there couldactually be multiple rows associated with the dilutant level Z6, one foreach dilution procedure. Thus, the crosscorrelation from the antigen ata dilutant level back to the amount of bass constitute antigen requiredto process through the diluting procedure requires knowledge of thediluting procedure. This is illustrated in FIG. 16A, wherein each columnfor the dilutant level D6 has three procedures such that there areprovided three different amounts of the base extract that would berequired, Z1, Z1′ and Z1″. For example, it might be that this requirescorresponding levels of 0.8 mL, 1.0 mL or 1.1 mL for those threedifferent levels in order to accommodate the three different dilutionprocedures S1, S2 and S3. Thus, it is not just a mere crosscorrelationoperation but, rather, and overall knowledge of the process that isrequired in order to determine how much actual product was utilized ofthe original base NDC-carrying antigen. Only when the amount of the baseconcentrate NDC-carrying antigen that is utilized is known can theactual dosage be determined. For reimbursement purposes, it is importantto know whether 0.8 mL, 1.00 mL or 1.1 mL of the base concentrateNDC-carrying antigen is utilized. Reimbursement is calculated based uponthis. However, all that is necessary for the pharmacist to do is to putin the end product that was generated and the procedure for coming upwith that end product and relate that to the NDC of the antigen that wasutilized.

Referring now to FIG. 17 , there is illustrated a flowchart for a secondexample for preparing a script for a cocktail, which is similar to theflowchart of FIG. 15 . This is initiated at a block 1702 and thenproceeds to a block 1704 to generate a script for a cocktail which is apatient-specific cocktail based upon a prick test performed. This isunique to that patient for that particular time. The program thenproceeds to a function block 1706 in order to provide in that script alist of the antigens to be placed into the cocktail by the pharmacist,the final dilutant level of each, the dosage and the particular carrier.The program then flows to a function block 1708 in order to select theprocedure that the pharmacist will utilize to provide this final dilutedproduct with the prescribed number of dosages. This might be prescribedby the physician or it might be selected by the pharmacist. The programthen flows to a function block 1710 wherein the pharmacist performs thedilution operation and then combines various antigens into the cocktail,at a block 1712. The program then proceeds to a function block 1714wherein the NDC for each antigen is entered into the database, the doselevel and the procedure. The program then proceeds to a function block1716 to parse the particular antigens at the database, this parsingrequired in order to process each antigen in the database separately, asthere must be a crosscorrelation back to each individual antigen, sinceonly each individual antigen has an NDC associated there with. Theprogram then proceeds to a function block 1718 in order to correlate theantigen back to the lowest concentrate NDC-carrying level, as describedhereinabove with respect to the embodiment of FIGS. 15 and 16 and thento a function block 1720 in order to define the benefits and then to afunction block 1722 in order to end the program, after the cocktail hasbeen distributed to the end user such as the patient or the medicalprofessional.

Referring now to FIG. 18 , there is illustrated a process, which issimilar to that described hereinabove, for creating a cocktail fromthree different base concentrate antigens 1302, 1304 and 1306, referringhereinabove to the description with respect to FIG. 13 . These arediluted down in five separate steps to a final dilution level D6. In afirst operation, there is provided a final vial 1802 that receives thefinal dosage from each of the processes for diluting the initial baseconcentrate levels. It may be that each of the final vials D6 each have5 mL contained therein. By containing no carrier material in the finalvial 1802, 3 mL of each of the extracts can be placed therein resultingin a vial with 9 mL therein. If the physician prescribed the regimen todeliver a 1 mL dose of this concentrated level three times per week forthree weeks, this would require nine doses and thus 9 mL of thecocktail. This overall process, for example, would require thepharmacist to understand each step of the dilution process to arrive atthe final diluted. Thus, the pharmacist would indicate that there werethree antigens in the final vial 1802 and that they were at theconcentrate level D6/D6/D6. This would be provided to the PDM database.With this information alone, the system at the PDM database can crosscorrelate this back to the exact amount of base concentrate level liesfor each of three base concentrate antigens 1302, 1304 and 1306utilized.

Alternatively, there is provided a vial 1804 which is the result of adifferent selection of cocktails from the D4 level. This, again, wouldhave the three antigens in the concentrate level D4/D4/D4. This wouldagain be provided to the PDM database which would then, based upon thedilutant level for each of the antigens and the procedure utilized toachieve that dilutant level to relate this back to the antigens utilizedat the lowest NDC-carrying concentrate level. If, for example, this vial1804 resulted in 9 mL of material but the physician only required threedoses of 1 mL each for two weeks, this would only require 6.0 mL. Thepharmacist might only dispense 6 mL out of the 9 mL to the patient orprofessional. Even though three doses were distributed or 6.0 mL, this 6mL of final product of D4/D4/D4 of Cat/Dog/Pollen, for example, or avenom derived antigen, antigen has to be related back to the originalantigen value.

In an alternate embodiment, there is a vial 1806 provided that has beenprovided where in it receives diluted antigens from slightly differentvials. In this operation, the three antigens are D5/D6/D6 and this isprovided back to the PDM database. Of interest is that all three vials1802, 1804 and 1806 will each be input to the PDM system with theirprocedure and the result will be that, for this example specifically,that the reimbursement be the same, as the starting dilutant will beidentical. This is procedure specific and script specific, with thecocktail noted as being patient-specific.

Referring now to FIG. 19 , there is illustrated an alternate embodimentwherein each of the base antigens 1302, 1304 and 1306 are subjected to adifferent procedure wherein each of the original starting amounts areinput to a first diluting vial 1902 and are subsequently diluted throughvials 1904, 1906, 1908 and 1910 to a final vial 1912. This is thendistributed to the patient. This final vial represents the dilution atthe vial 1910, which is D6/D6/D6. This, along with this procedure, isthen transferred to the PDM database, as indicated by block 1920, whichis then parsed to the specific antigens and into a translator associatedwith each antigen, indicated by a “X” for the crosscorrelationoperation, blocks 1922, 1924 and 1926 associated with the Dog, Cat andPollen antigens, or venom derived antigens, which will then define thereimbursement. Each translation block 1922 will be associated with areimbursement database for defined benefits associated with theparticular antigen. Of course, it is important to know the amount ofantigen that was actually utilized in the overall procedure which,again, requires knowledge of the final script dilutant level of theantigen delivered to the patient and procedure for obtaining thatdiluted level.

Referring now to FIG. 20A, there is illustrated a diagrammatic view ofan overall process where in the NDC is associated with an intermediatelevel of dilutant. In this embodiment, the dilutant level D4 isillustrated as having an NDC associated there with, as well as the baseconcentrate level of. Thus, it is possible that the reimbursement and bedefined back to this intermediate concentrate level. This is indicatedin a table in FIG. 20B, wherein the table can have associated withoriginal diluted levels D4, D5 and D6 crosscorrelation relationshipswith respect to the base concentrate level but, in this table, there areonly three diluted levels required, the dilutant level for vial D4, thevial D5 and the vial D6. If the concentrate level at the final vial wasX3 based upon the NDC code being at vial D4, all that would be requiredis to do a crosscorrelation back to the dilutant level required from thevial D4. This would be for each of the dilutant set was combined in avial 2002 from each of the antigens in the script, this indicated asbeing the antigens A1-N.

Referring now to FIG. 21 , there is illustrated a process for mappingprick test to the script. As illustrated, there is provided a diagram ofthe prick test, indicated by a reference numeral 2102. This diagram 2102indicates the locations of the particular allergens that wereadministered to locales on the person of the patient. This diagramillustrates the results with a “P” indicating a positive reaction andthat an “X” indicating a negative reaction. Thus, the “P” indicates asensitivity that must be considered in the script. Of interest is thatthe particular manufacturers of antigens might have a cocktail alreadyexisting in the base concentrate. This is illustrated with the bottomthree test associated with antigens A(n−2), A(n−1) and AN. These are thelast three antigens in the list. Of these, the last two are positive andthe third for the last is negative. However, the script will have toinclude only the last two for the patient-specific script but thepharmacist only has the cocktail of all three available to them. Thus,the script will have a A0, A1, A3, A4 . . . , A(n−1) and AN as theantigens that are required for the desensitization regimen. This will beprovided to the pharmacist which will then select NDC-carrying antigenbottles A0, A1, A3, A4 . . . , And finally a bottle 2102 containingA(n−2), A(n−1) and AN, wherein only A(n−1) and AN are required in scriptto fill the prescription. This is then processed to provide the finalpatient dosage in the cocktail in the vial 2104.

Referring now to FIG. 22A, there is illustrated a flowchart depictingthe overall parsing operation before the operation of FIG. 21A. In thisoperation, if the base NDC has a greater number of antigens than thescript, a decision block 2202 will determine such and flow to a block2204. The program will then flow to a function block 2206 in order todetermine the base dosage for the script as required by and set forth bythe physician of the antigens with the particular NDC, even though thatNDC is associated with more than the antigens required by the script.The program then flows to a function block 2208 in order to determinethe benefits. This is illustrated best with respect to the table of FIG.22B. Here, it is illustrated that there are three procedures forproviding the end dilutant level at the vial D6 for each of the antigensin the cocktail antigen vial 2102. If a certain amount of antigen isextracted from this particular vial 2102, it will contain all threeantigens. At a particular concentrate level at the level D6, this willyield the necessary concentrated level of the two antigens desired eventhough the third antigen is included. Since the final dilutant level isknown for the two prescribed antigens, they can be cross correlated backto the amount of antigen that was actually extracted. However, forexample, if 3 mL of the extract in vial 2102 were extracted, this mightrepresent a particular portion of a 100 mL bottle and, if all threeantigens have been prescribed, this would be the basis for thereimbursement. However, if only two antigens were prescribed, only twothirds of that prescribed extract would be reimbursed. Thus, byutilizing known script at the known dilutant level, this can be crosscorrelated back via the standard procedure (or whatever procedure isutilized) to what was actually utilized of the NDC-carrying baseconcentrate material to actually derive the final prescribed anddelivered antigen to the patient.

Although the preferred embodiment has been described in detail, itshould be understood that various changes, substitutions and alterationscan be made therein without departing from the spirit and scope of theinvention as defined by the appended claims.

What is claimed is:
 1. A method for adjudicating reimbursement forallergens, the method comprising: diluting a plurality of allergens,wherein each of the plurality of allergens is diluted by the steps of:extracting a defined amount of concentrated allergen extract from acontainer of concentrated allergen extract and disposing it within afirst one of a plurality of sterile containers containing a dilutant, toprovide a first dilution level, wherein each of the plurality of sterilecontainers is associated with a different dilution level, extracting adefined amount of diluted allergen from the first one of the sterilecontainers and disposing it within a second one of the sterilecontainers to provide a second dilution level, and progressivelyextracting a defined amount of diluted allergens from a previous one ofthe sterile containers to a next thereof containing a dilutant toprovide progressively more diluted levels until a last of the sterilecontainers containing a final dilution level, to provide a plurality ofdefined concentration levels of diluted allergens, and obtaining, at acentral control center, National Drug Codes (NDCs) for the plurality ofallergens each at one of the plurality of defined concentration levelsof diluted allergens, each NDC uniquely identifying a particularallergen as to its manufacture, the particular allergen, packaging, anda defined concentration level of the particular allergen, and furtherobtaining information as to a description of the particular allergen,the defined concentration level of the particular allergen, andmanufacturer of the particular allergen; determining, by the centralcontrol center, an Average Wholesale Price (AWP) for each of theallergens associated with one of the NDCs; storing, in a central controldatabase, the NDCs in association with an associated Average WholesalePrice (AWP) and associated information for NDC-carrying allergens, whichassociated information allows practitioners to determine from a dilutedlevel and number of doses of one of the NDC-carrying allergens and aknown dilution procedure how to translate back to an amount of a baseconcentrate of the one of the NDC-carrying allergens used to create thediluted level and number of doses; accessing a third-party databaseaccessible by a pharmacist and determining if any of the NDCs in thecentral control database are contained within the third-party databaseand, if not: transferring NDCs not in the third-party database and thatexist in the central control database for each of the allergens to thethird-party database with the associated AWP and associated informationfor each of the allergens for each of the NDCs, and uniquely associatingeach of the NDCs in the third-party database to the central controlcenter for adjudication information; and creating an adjudicatingdatabase at the central control center having defined benefitsassociated with reimbursable entities for each of the NDCs stored in thethird-party database and in the central control database in associationwith the associated information for each of the NDC-carrying allergens.2. The method of claim 1, wherein the base concentrate of the one of theNDC-carrying allergens is any concentration level that is too toxic fora patient to be exposed to.
 3. The method of claim 1, and furthercomprising the step of a physician creating a script defining a desireddiluted level and a number of doses of at least one of the NDC-carryingallergens.
 4. The method of claim 3, wherein the script includes desireddiluted levels to be included within each dose.
 5. The method of claim3, wherein diluting the plurality of allergens is performed by apharmacist, and includes diluting the at least one of the NDC-carryingallergens to the desired diluted level and the number of doses definedby the script.
 6. The method of claim 1, wherein the associatedinformation includes a table of dilution levels of the one of theNDC-carrying allergens associated with a plurality of dilutionprocedures wherein each of the dilution levels defines the number ofdoses at the dilution level and, via the known dilution procedure, theamount of the base concentrate of the one of the NDC-carrying allergensrequired to yield the dilution level and the number of doses.
 7. Themethod of claim 6, wherein each of the NDC-carrying allergens is definedas being able to be distributed in discrete quantities, each of thediscrete quantities associated with a starting level of an NDC-carryingallergen and each of the discrete quantities adjudicatable.
 8. Themethod of claim 1, further comprising determining, by the centralcontrol center, the associated AWP for each of the allergens associatedwith one of the NDCs based on the obtained information as to thedescription of the particular allergen, the defined concentration levelof the particular allergen, and the manufacturer of the particularallergen.
 9. The method of claim 1, further comprising: generating alink in the third-party database associated with a particular NDC of oneof the NDCs that directs to the adjudicating database to obtaininformation regarding reimbursable benefits from the central controlcenter and enter the diluted level and the number of doses and a claimwith the central control center for adjudication of the amount of thebase concentrate of the NDC-carrying allergen of the one of the NDC's,and wherein the central control center is able to process any claim madeby a pharmacist and reimburse the pharmacist accordingly for the amountof the base concentrate of the NDC-carrying allergen used to provide thediluted level and number of doses of the NDC-carrying allergen.
 10. Themethod of claim 9, further comprising: defining, based on the generatedlink in the third-party database, the central control center as an ownerand a provider of the particular NDC, wherein the generated link causesthe central control center to be associated with each of the NDC's forwhich a unique link is generated and causes the central control centerto be automatically included in adjudication of the plurality ofallergens.